Clinical - Clinical Trials Disclosure Specialist

Position Overview :

• The Clinical Trial Disclosure Senior Specialist will provide the operational support of : Redaction of clinical trial documents in accordance with evolving global regulations.
• Key business partners are Clinical Development / Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers.

Responsibilities :

• Manage and Coordinate redaction of clinical documents in accordance with EMA Policy , Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
• Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
• Provide vendor oversight to support document redactions
• Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
• Manage and track redaction book-of-work; compile and report on volume and performance metrics
• Provide operational support to CT Results Specialists, as required
• Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
• Communicates with internal and external stakeholders to improve on processes and manage unmet need
• Trains new staff and develops job aids, work instructions, and user guides, as needed

Qualifications :

• BA / BS or MA / MS in scientific or medical field
• 2-3 years of document redaction and 3+ years relevant work experience in a scientific or medical field with BA / BS
• Deep understanding of US / Canada and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA / EFPIA principles for responsible data sharing, etc.)
• Familiarity and comfortability working with and discussing scientific data
• Project and stakeholder management experience
• Demonstrated ability to work independently and seek out support when needed
• Exceptional written and oral communication skills
• Strong organizational skills with the ability to multitask and prioritize

If hired, you will enjoy the following ECLARO Benefits :

• k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

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